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Informed consent in gerontology.
Rosana Soibelmann Glock1, Jose Roberto Goldim
1Comite de Etica em Pesquisa da PUCRS, Ave. Ipiranga, 6690, 90619-900 Porto Alegre, RS - Brazil. rglock@pucrs.br
Informed consent documents for elderly research in Brazil are often too complex for participants, hindering comprehension. Researchers must improve clarity and the consent process for older adults in gerontology studies.
Area of Science:
- Gerontology
- Bioethics
- Clinical Research
Background:
- Informed consent is crucial for ethical research.
- Elderly populations may face unique challenges in understanding research information.
- Adequacy of informed consent in Brazilian gerontology research requires evaluation.
Purpose of the Study:
- To assess the use and adequacy of informed consent for elderly participants in Brazil.
- To identify challenges in comprehension and the informed consent process.
Main Methods:
- Utilized a reading index to evaluate text complexity of informed consent forms.
- Compared investigator and elderly participant perceptions of text accessibility.
- Assessed the timing of decision-making relative to consent form review.
Main Results:
- 83% of informed consent forms were difficult to read, requiring higher education than participants possessed.
- A significant disparity existed between investigators (100% accessible) and elderly participants (75% difficult) regarding text comprehension.
- 94% of elderly participants decided to join before reading the consent form.
Conclusions:
- Informed consent forms in gerontology research in Brazil are frequently inadequate.
- The informed consent process needs significant improvement, focusing on text clarity and participant understanding.
- Continuous review of the informed consent process at each participant encounter is recommended.
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